Bristol-Myers Squibb announces positive Phase I study data for Opdivo in haematological malignancies

Bristol-Myers Squibb said that its PD-1 checkpoint inhibitor Opdivo (nivolumab) achieved positive results in an early-stage study of patients with relapsed or refractory haematological malignancies. According to data from the CheckMate-039 study, which were reported at the American Society for Hematology annual meeting and also published in the NEJM, an overall response rate was observed in 87 percent of patients, while the remaining 13 percent of patients exhibited stable disease. Bristol-Myers Squibb senior vice president Michael Giordano commented "these new data from Opdivo represent the next step towards our goal of identifying therapies that can transform the standard of care across a variety of cancer types."

In the current cohort, 23 patients with various haematological malignancies were treated with Opdivo at week one, week four and every two weeks thereafter until disease progression or complete response, or for a maximum of two years. The primary endpoints of the trial were the tolerability and safety of Opdivo, while the secondary aims included the drug's immunogenicity, anti-tumour activity and pharmacokinetics, as well as assessments of PD-L1 and PD-L2 expression as predictive biomarkers.

Bristol-Myers Squibb noted that the patients who achieved an overall response included four patients who experienced a complete response and 16 patients who exhibited a partial response. Of these patients, 60 percent achieved a response within eight weeks of treatment. Further, the progression-free survival rate after 24 weeks of treatment was 86 percent. According to the drugmaker, 78 percent of patients experienced a drug-related adverse event, most commonly rash and a decreased platelet count. No Grade 4 or Grade 5 adverse events were reported.

"What makes these results especially encouraging is that they were achieved in patients who had exhausted other treatment options," remarked study author Margaret Shipp. The researchers added "we're also excited by the duration of responses to the drug: the majority of patients who had a response are still doing well more than a year after their treatment."

Bristol-Myers Squibb and partner Ono Pharmaceutical launched Opdivo in Japan in September at a price of $143 000 per year. ​Also in September​, Merck & Co.'s Key​​truda (pembrolizumab) became the first drug in this class to gain clearance in the US.

For related analysis on the PD-1 inhibitor class, see ViewPoints: Excitement but uncertainty shapes melanoma market as PD-1 inhibitors encroach and ViewPoints: Immuno-oncology movement into haematological cancers gathers pace.

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